A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease

Eisai Clinical Trials

A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer’s Disease

Protocol # E2020-C086-339

Study Overview

Study Compound: E2020

Drug Name: donepezil

Registry #: NCT01404169

Trial Period: Sep 2011 - Jul 2014

Indication: Alzheimer's disease

Primary Endpoint: To demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy compared with placebo for changes from Baseline to Week 24 in cognitive function in Chinese participants with severe Alzheimer's disease.

Population
Male and female patients (aged 50 to 90 years)
Study Status
Completed
Study Phase
Phase 3
Countries
China

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Jia J, Wei C, Jia L, Tang Y, Liang J, Zhou A, et al. Efficacy and Safety of Donepezil in Chinese Patients with Severe Alzheimer’s Disease: A Randomized Controlled Trial. Journal of Alzheimer’s Disease. 2017;56:1495-504.

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

Redacted documents are available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR